December 4, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Indianapolis-based Eli Lilly and Company announced today that it is ending its basal insulin peglispro (BIL) development efforts for Type 1 and Type 2 diabetes.
On Feb. 23, 2015, the company announced it was delaying the BIL submission to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Eli Lilly indicated it wanted to create extra clinical data regarding changes in liver fat that had been noted in Phase III trials.
At that time, 6,000 patients had been evaluated for up to 18 months, about 3,900 of them on BIL. No liver impairment was observed or indication of Hy’s Law cases. Hy’s Law are general guidelines indicating a drug might have a high risk of causing drug-induced liver injury (DILI).
BIL was being evaluated as a once-daily treatment for Type 1 and 2 diabetes. It is a type of insulin.
The company evaluated the challenges it would face in providing additional data and taking BIL to market based on what it knew to date about the liver fat issue. Although there were no new safety issues, the company decided the risks were greater than the rewards of continuing.
“While we are encouraged by the efficacy data we observed for BIL, we know that moving forward would have required a significant amount of time and investment with no assurance that we would find conclusive answers,” said Enrique Conterno, president of Lilly Diabetes, in a statement. “We are disappointed in the outcome for Bil, but we have an unprecedented opportunity to build upon the industry’s broadest diabetes portfolio, which includes six new treatments approved since the middle of 2014. Lilly remains fully committed to innovative research in the diabetes space, including insulins, as we strive to make life better for people around the world.”
Although somewhat volatile, Eli Lilly has been on a relative high the last half of this year. Shares traded for $68.07 on Mar. 6, 2015, rose to $88.82 on July 13, and spiked for a yearly high on Sept. 17 to $89.98. Shares then dropped on Oct. 22 to $76.98, and started recovering to $86.50 on Dec. 1. Shares dropped slightly on today’s news, currently trading for $83.07.
The company has not indicated if any jobs will be cut as part of the termination of the BIL program. Overall the company has been expanding technical facilities. In October the company announced it was expanding its facilities at the Alexandria Center for Life Science in New York City. It plans to hire 50 new employees and add 30,000 square feet of space.
In July, the company announced it was expanding its Lilly Biotechnology Center in San Diego, Calif., increasing staff by 70 percent and upping its space by 140 percent. That amounts to about 130 new jobs. And in April, the company announced it was expanding its facilities in Cambridge, Mass., hiring 30 more scientists and engineers.
